Assessment of Progesterone Receptors in Breast Carcinoma by Positron Emission Tomography (PET) Using Fluoro Furanyl Norprogesterone (FFNP)

Breast Cancer Clinical Trial

— FFNP  

Official title:

Labeling of Receptor Ligands and Other Compounds With Halogen Radionuclides: Assessment of Progesterone Receptors in Breast Carcinoma by Positron Emission Tomography (PET) Using FFNP

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00968409
• Other study ID #: FFNP 06-1034
• Status: Completed
• Phase: Phase 1
• First received: August 28, 2009
• Last updated: December 7, 2015
• Start date: January 2007
• Est. completion date: January 2011

Study information

• Verified date: December 2015
• Source: Washington University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to see if Positron Emission Tomography (PET) imaging with a radioactive form of the hormone progesterone called FFNP will give the same results as hormone receptor testing already performed on tissue used to diagnose breast cancer.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: January 2011
• Est. primary completion date: January 2011
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Female patients 18 years of age or older

• Biopsy-proven breast cancer

• Tumor estrogen-receptor and progesterone-receptor status already determined or scheduled to be determined at time of surgery without intervening therapy.

• Primary lesion size = 1.5 cm as determined by imaging studies (ultrasonography, mammography, CT or MRI) or physical examination

• Able to give informed consent

• Not currently pregnant or nursing: Subject must be surgically sterile (has had a documented bilateral oophorectomy and / or documented hysterectomy), post menopausal (cessation of menses for more than 1 year), non lactating, or of childbearing potential for whom a urine pregnancy test (with the test performed within the 24 hour period immediately prior to administration of FFNP) is negative.

Exclusion Criteria:

• No previous history of hormone therapy; NOTE - subjects who were treated with hormone therapy for reasons other than breast cancer or breast cancer prevention may be allowed to participate after review of history by the primary investigator

• Patients with other invasive malignancies, with the exception of non-melanoma skin cancer, who had (or have) any evidence of the other cancer present within the last 5 years

• Unable to tolerate 60-90 minutes of PET imaging per imaging session

Study Design

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Radiation:
• PET
PET imaging following injection of F18-FFNP to image hormone receptor status in patients with newly diagnosed breast cancer

Other:
• Laboratory Testing
Blood and urine samples for standard laboratory testing and radioactive counts will be obtained during the imaging sessions. Testing will include: urinalysis, complete blood count, comprehensive metabolic panel, and progesterone levels
• Safety Testing
ECG tracings and vital signs (blood pressure, heart rate, body temperature and respiration rate) are obtained at several time points before, during and after the imaging sessions.

Drug:
• F18-FFNP
injection of F18-FFNP

Locations

Country	Name	City	State
United States	Washington University / Barnes-Jewish Hospital	Saint Louis	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
Washington University School of Medicine

Country where clinical trial is conducted

United States, 

References & Publications (1)

Dehdashti F, Laforest R, Gao F, Aft RL, Dence CS, Zhou D, Shoghi KI, Siegel BA, Katzenellenbogen JA, Welch MJ. Assessment of progesterone receptors in breast carcinoma by PET with 21-18F-fluoro-16a,17a-[(R)-(1'-a-furylmethylidene)dioxy]-19-norpregn-4-ene- — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Diagnostic accuracy of FFNP-PET imaging compared to in-vivo receptor status		4 years	No
Secondary	To assess the diagnostic quality of FFNP-PET images at the proposed 10.0 mCi dose		4 years	No
Secondary	To determine the relationship between tumor FFNP uptake and in vitro status of progesterone receptor		4 years	No
Secondary	To calculate human dosimetry and overall safety of FFNP-PET imaging		4 years	Yes